UCI as the Relying IRB

Current UCI policy requires that all faculty, staff, and students must have UCI IRB approval before they begin research with human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities.

UCI will consider relying on another institution for IRB review on a protocol by protocol basis when a UCI investigator is engaged in human subjects research with a non-UC investigator and:

  • The non-UCI investigator is the prime recipient of the funding award, or
  • The PI of the study is affiliated with the Reviewing IRB’s institution, or
  • The research will primarily take place at the Reviewing IRB’s institution, or
  • The other institution’s reviewing IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context, and
  • The UCI investigators will conduct human research activities that involve no more than minimal risk to subjects, and
  • The other institution is located within the United States.

To facilitate human research and in response to requests by investigators for a more streamlined IRB review process UCI allows for researchers to request that UCI rely on a non-UCI IRB.  This may be indicated through the UCI IRB Application process. Include a copy of the approved study documents from the Reviewing IRB. The UCI IRB will then make a determination as to whether it is appropriate to defer to another IRB, and will notify the investigator of the decision. Note: accepting the review of another IRB does not eliminate the UCI investigator’s responsibility to seek approval from other applicable UCI regulatory entities (e.g., Institutional Biosafety Committee, Radiation Safety Committee, and Human Stem Cell Research Oversight Committee). Please contact the HRP staff for more information.

Reliance Agreement Tables

Commercial Agreements

COMMERCIAL IRB AGREEMENTONLINE PORTALUCI GUIDANCESHORT FORMAMENDMENTSRENEWALSREPORTABLE EVENTS
TO IRB OF RECORDAND TO UCI
WCG IRBConnexusInfoDefer to UCI’s Use of Short Form (Policy 31)All changes

1. Personnel changes


2. Changes affecting HIPAA

Submit the Renewal Letter approved by the IRB of Record directly in KR Protocols

Reporting Requirements


Submit ‘Reportable Info Form’ via Connexus

AdvarraCIRBIInfo

Reporting Requirements


Guidelines

Other Agreements

OTHER AGREEMENTSHOW TO SUBMIT NEW STUDIES TO UCI IRBONLINE PORTALUCI GUIDANCEAMENDMENTSRENEWALS
UCI AS IRB OF RECORDUCI RELYINGTO IRB OF RECORDAND TO UCI
UC RelianceSMART IRBUCI Relying

UC Reliance Registry


Creating a new study


Relying PI Sign-Off

InfoAll Changes

1. Personnel changes


2. Changes affecting HIPAA

Submit the Renewal Letter approved by the IRB of Record directly in KR Protocols
National Cancer Institute (NCI) Central IRB (CIRB)N/AGeneral InfoCancer Therapy Evaluation Program (CTEP)Info
National Institutes of Health (NIH) single IRB (sIRB) ReviewN/AUCI RelyingN/AInfo
SMART IRBSMART IRBUCI RelyingOnline Reliance SystemInfo
CHOC-MHS-UCI (CMU)SMART IRBSMART IRBN/AInfo
StrokeNetN/AUCI RelyingN/AN/A
NeuroNEXTN/AUCI RelyingN/AN/A
Single Agreements (e.g., Chapman, Fountain Valley, Kaiser)

SMART IRB


IRB Authorization Agreement


Individual Investigator Agreement

UCI RelyingN/AInfo
Online PortalN/AN/ATrial Innovation Network (TINs)N/A
Online PortalN/AN/AIRB Reliance Exchange (IREx)N/A